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【medical-news】FDA授权第一个用于移动设备的放射
FDA NEWS RELEASE
For Immediate Release: Feb. 4, 2011
Media Inquiries: Erica Jefferson, 301-796-4988; erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA clears first diagnostic radiology application for mobile devices
Provides wireless access to medical images for iPhone, iPad users
A new mobile radiology application cleared today by the U.S. Food and Drug Administration will allow physicians to view medical images on the iPhone and iPad manufactured by Apple Inc.
The application is the first cleared by the FDA for viewing images and making medical diagnoses based on computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine technology, such as positron emission tomography (PET). It is not intended to replace full workstations and is indicated for use only when there is no access to a workstation.
“This important mobile technology provides physicians with the ability to immediately view images and make diagnoses without having to be back at the workstation or wait for film,” said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health.
Radiology images taken in the hospital or physician’s office are compressed for secure network transfer then sent to the appropriate portable wireless device via software called Mobile MIM. Mobile MIM, manufactured by Cleveland-based MIM Software Inc., allows the physician to measure distance on the image and image intensity values and display measurement lines, annotations and regions of interest.
In its evaluation, the FDA reviewed performance test results on various portable devices. These tests measured luminance, image quality (resolution), and noise in accordance with international standards and guidelines. The FDA also reviewed results from demonstration studies with qualified radiologists under different lighting conditions. All participants agreed that the device was sufficient for diagnostic image interpretation under the recommended lighting conditions.
The display performance of mobile devices can experience significant variations in luminance levels even between mobile devices of the same model. The Mobile MIM application includes sufficient labeling and safety features to mitigate the risk of poor image display due to improper screen luminance or lighting conditions. The device includes an interactive contrast test in which a small part of the screen is a slightly different shade than the rest of the screen. If the physician can identify and tap this portion of the screen, then the lighting conditions are not interfering with the physician's ability to discern subtle differences in contrast. In addition, a safety guide is included within the application. 临床PET/CT诊断学_百度百科第二节PET临床应用及国产PET发展简介 一、PET的临床应用与FDA认证 二、国产PET... 第一节正电子显像剂进展 第二节正电子显像剂的一般性质量要求 附正电子类放射性药品...baike.baidu.com/...2614462.htm-2009-07-08-快照-诊断学_百度百科" 第一部分 肿瘤学进展文件类型:PDF/Adobe Acrobat- 文字版(1) 根据病毒形态分类:A、B、C、D (2) 根据病毒基因组结构是否完整分类: 非缺陷型... 信号传导分子;转 录因子;细胞程序性死亡及凋亡基因和细胞周期蛋白等 第一节 癌基因研...www.immc.edu.cn/...g/e/1/1.pdf-2011-01-29-第一部分 肿瘤学进展" 诊断学2009——走向个性化医学【1】-姜广策的博客-要么第一要...诊断学2009,是针对体外诊断产业商业活动和快速崛起的个性化医学的第一个年度报告. ... 相关的诊断行业包括用于体内(而非体外)诊断的医学成像和电子医疗设备行业.我们将不...zhishuirenshan.blog.sohu.com/...-2010-12-11-快照-诊断学2009——走向个性化医学【1】-姜广策的博客-要么第一要..."[标签:content2]
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作者:admin@医学,生命科学 2011-02-06 12:24
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